IVF Clinical Trial - Gene-polymorphisms Relating to Human Subfertility

Status Completed

Clinical Trial Summary

Estradiol is synthesized by granulosa cells of ovaries under control of follicle-stimulating hormone (FSH) and luteinizing hormone (LH). It is known that Estradiol plays a crucial role in maturation and fertilization of oocytes. Furthermore it is involved in development of secondary female sexual organs, fertility and maintenance of pregnancy.

Estradiol influences these processes by binding to estradiol receptors (ER). They are ligand-depending transcription-factors. In humans there are two subtypes: ERa and ERb, which are synthetized from gene ESR1 on chromosome 6 and ESR2 on chromosome 14. Both subtypes are expressed in the ovary. Both genes are polymorph. Especially for ERa subtype several polymorphisms and mutations are known which can be linked to breast cancer, spontaneous abortions, osteoporosis and the point in time of menarche. Furthermore some studies have shown a relationship between certain polymorphisms and the risk of infertility associated gynecological malfunctions and the result of IVF treatments.

Progesterone is a hormone which plays a crucial role in initiation and maintenance of pregnancy. It induces the transformation of the endometrium, which facilitates the implantation of the fertilized oocyte and supports the pregnancy. Progesterone acts by binding to its receptor. The gene for this receptor is polymorph within the population, whereas some variants seem to account for implantation failure of embryos.

In the investigators study the investigators will analyse the role of ERP and PRP polymorphisms in the context of IVF treatment. The analyzed genotypes are two polymorphisms of ESRI, called Pvu and Xba, as well as a variant of ESRII, ER2. In the progesterone receptor gene a single nucleotide exchange at position +331 (G->A) plays a role.

The parameters correlated with are concentrations of estradiol, progesterone and FSH, number of follicles, number of fertilized oocytes and pregnancy rate.

The investigators hope to optimize established treatment protocols and to improve the chances of success of IVF treatments depending on the genotype of the patient.

Clinical Trial Description

n/a

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

Estradiol Receptor Polymorphism
Infertility
IVF
Progesterone Receptor Polymorphism
Subfertility

Clinical Trial Details

NCT number	NCT01385618
Study type	Observational
Source	Infertility Treatment Center Dortmund
Contact
Status	Completed
Phase	N/A
Start date	October 2010
Completion date	March 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05969574` - Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
Completed	`NCT04778358` - Higher Dose of Rekovelle in Oocyte Donors	Phase 2
Completed	`NCT04052464` - The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
Completed	`NCT04108039` - Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.	N/A
Suspended	`NCT04669652` - Evaluating Piezo-ICSI. - The EPI Study.	N/A
Completed	`NCT04524026` - RIOTC: Reducing the Impact of Ovarian Stimulation. Novel Approaches to Luteal Support in IVF-Study 2	Phase 2
Recruiting	`NCT05981898` - Opt-IVF Multi-center Trial 2 Including All Protocols	N/A
Recruiting	`NCT05737381` - Quality of Human Embryos in IVF, Culturing in Differentiated Oxygen	N/A
Recruiting	`NCT04447872` - The LUTEAL Trial: Luteal Stimulation vs. Estrogen Priming Protocol	N/A
Completed	`NCT04425317` - Detection of SARS-CoV-2 in Follicular Fluid and Cumulus-oocyte-complexes in COVID-19 Patients	N/A
Not yet recruiting	`NCT05932082` - The Impact of Myomectomy on IVF Outcomes	N/A
Not yet recruiting	`NCT04283435` - Endometrial Effects of Sildenafil in Frozen-Thawed Cycles in Women With Thin Endometrium	Phase 1
Recruiting	`NCT04654741` - The Rate of Embryo Euploidy in Progestin-primed Ovarian Stimulation Cycles	Phase 4
Completed	`NCT04099784` - Health of Frozen Transferred Versus Fresh Transferred Children
Recruiting	`NCT05788822` - MVA to Improve the Pregnancy Outcome in Aged Infertility Women With Assisted Reproductive Technology	N/A
Completed	`NCT04956848` - Comparing KIDScore™ D5 and iDAScore®. The KiDA Study	N/A
Not yet recruiting	`NCT06048666` - Platelet Rich Plasma on Ovarian Reserve Parameters and Intra Cytoplasmic Sperm Injection Outcomes in Patients With Diminished Ovarian Reserve	Phase 3
Not yet recruiting	`NCT05954962` - Efficacy of Micronized Natural Progesterone vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.	Phase 4
Not yet recruiting	`NCT02698488` - Embryo Selection by Metabolomic Profiling of Embryo Culture Medium With Mass Spectroscopy as an Adjunct to Morphology	N/A
Recruiting	`NCT05893238` - Human Follicular Fluid Markers and Reproductive Outcomes in IVF

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.